As In Vitro Diagnostic test kits' professional manufacture, we comply strictly with QSR ( Quality Systems Regulation )--TUV ISO 13485 from Germany and FDA from U.S.，all of products are manifactured in GMP( Good Manufacture Practice) condition. Most of our biochemistry raw materials(Conjugation Antibody/Antigen,etc. ) are imported from our experts' lab( Bioassayplus Inc.) in Canada , there is a professional R&D team to assure the origin of raw material is qualified. We promise all of our products is qualified by the famous international autherized orgnization in the world.